News – USA – BrainStorm Announces High Level FDA Feedback on NurOwn® ALS Clinical Development Program


NEW YORK, Feb 22, 2021 / PRNewswire / – BrainStorm Cell Therapeutics Inc (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that it recently met with executives at US Food and Drug Administration (FDA) and received FDA feedback on a high-level summary of data from the NurOwn Phase 3 Clinical Trial (MSC-NTF Autologous Cells) The FDA concluded from its initial review that the The current state of clinical data does not constitute the threshold for substantive evidence that the FDA is seeking to endorse a Biologics License Application (BLA)Additionally, the FDA noted that this recommendation does not prevent Brainstorm from proceeding with a BLA filing

“Brainstorm will first consult lead researchers, ALS experts, expert statisticians, regulatory advisors and ALS stakeholders to assess the benefit / risk of a BLA filing before making a final decision,” said Chaim Lebovits, CEO of Brainstorm Cell Therapeutics “We would like to thank our independent advisors for their openness and unwavering commitment to our ALS program. We would also like to extend our heartfelt thanks to all of the ALS patients and their families who have been involved in this clinical research program. The company will continue to be present at the Build up the strength of his wonderful, professional and committed team and at the same time with a current position of over 40 million US $ in cash will be well funded We will shortly announce our next flagship product and program for other diseases with unmet need “

“Many of us with years of experience in the development of ALS therapy agree that there has been evidence of a benefit from NurOwn cell therapy and hope that there will be an opportunity to further evaluate this modality in ALS” said Robert Brown, DPhil, MD, director of the Neurotherapeutic Program at the University of Massachusetts Medical School

“ALS is a devastating disease with worse outcomes than most cancers,” said Dr Anthony Windebank, Jean and Judith Pape Adams, Professor of Neuroscience at Mayo Clinic College of Medicine and Science “The clear signal in this study that some patients with ALS are responding to treatment with NurOwn is a light at the end of the tunnel that carefully examines the Biomarkers associated with response will guide us to broader therapy. The patients and their families who have brought us to this point are true heroes “

“I am deeply grateful to the patients and families who participated in this phase 3 study and to all the teams at the six sites,” said Dr Merit Cudkowicz, Chief of Neurology and Director of Healey & AMG Center for ALS at Mass General Hospital and Julieanne Dorn Professor of Neurology at Harvard Medical School “In this well-conducted study, we learned a lot about the efficacy and safety of NurOwn in people with ALS We also learned about some of the challenges of using ALSFRS-R at the lower end of the scale. Additional discussions with the community and sharing all of the data in an peer-reviewed publication are important next steps “

“We will conduct all ALS Phase 3 study analysis to aid in scientific communication of the Phase 3 data, including an peer-reviewed manuscript,” said Ralph Kern, MD MHSc, President and Chief Medical Officer of Brainstorm Cell Therapeutics “The results of the Phase 3 clinical trial are very important and we are confident that analyzing the key biomarkers for ALS diseases will add to our understanding of ALS. Our focus is on advancing our proprietary cellular platform and prioritizing of product development efforts based on data and business priorities “

The NurOwn® technology platform (autologous MSC-NTF cells) is a promising therapeutic approach to the investigation of pathways important in neurodegenerative diseases MSC-NTF cells are made from autologous, bone marrow-derived mesenchymal stem cells (MSCs) Manufactured That Have Expanded and Differentiated Ex vivo MSCs are converted into MSC-NTF cells by growing them under patented conditions that cause the cells to secrete high levels of neurotrophic factors (NTFs) Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of the lesion to produce a desired biological effect and ultimately to slow or stabilize the progression of the disease

BrainStorm Cell Therapeutics Inc is a leading developer of innovative autologous adult stem cell therapeutics for the weakening of neurodegenerative diseases.The company owns the rights to clinical development and commercialization of the NurOwn® technology platform, which is used to manufacture autologous MSC-NTF cells under an exclusive worldwide license agreement, Autologous MSC-NTF Cells have received orphan drug designation status from the U Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS) BrainStorm has completed a Phase 3 registration study for ALS (NCT03280056) This study evaluated the safety and effectiveness of repeated administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989) BrainStorm is also conducting an FDA-approved, open, multicenter, phase 2 study for the treatment of progressive multiple sclerosis (MS) The Phase 2 study with autologous MSC-NTF cells in patients with progressive MS (NCT03799718) was completed in December 2020 The results of the topline are expected by the end of the first quarter of 2021

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute “forward-looking statements” and involve risks and uncertainties that BrainStorm Cell Therapeutics IncActual results will differ materially from those expressed or implied in these forward-looking statements. Terms and expressions such as “may,” “should,” “would,” “could,” “will,” “expect,” “likely,” “believe.” “,” plan, “” estimate, “” forecast, “” potential “and similar terms and expressions are used to identify these forward-looking statements. Potential risks and uncertainties include, but are not limited to, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue operations, the prospect of regulatory approval of BrainStorm’s NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm’s product development programs and research, regulatory, and human resource issues, developing a global market for our services, the ability To secure research facilities for the implementation of our clinical studies and maintain, the ability to generate significant revenue, the ability of the NurOwn® treatment candidate from BrainStorm to achieve wide acceptance As a treatment option for ALS or other neurodegenerative diseases, BrainStorm offers the ability to manufacture or market the NurOwn® treatment candidate, and receives patents that offer meaningful protection, competition and market developments BrainStorm’s ability to protect our intellectual property from third party violations, health reform laws, demand for our services, exchange rates, as well as product liability claims and litigation; and other factors set out in BrainStorm’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q available at http://www.sekGovernment These factors should be carefully considered and readers should not feel inappropriate Relying On BrainStorm Forward-Looking Statements The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We undertake no obligation to update any forward-looking statements to reflect actual results or assumptions if circumstances or Management’s beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations contained in the forward-looking statements are reasonable, we cannot guarantee future results, activities take over ies, achievements or successes

Brainstorm Cell Therapeutics, NASDAQ: BCLI, Food and Drug Administration, Amyotrophic Lateral Sclerosis, Cell Therapy, Stick, Clinical Trial, Nasdaq

News – USA – BrainStorm Announces High Level FDA Feedback on NurOwn ® ALS Clinical Development Program
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